FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
118297–118320 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1992
HL-300 RECEIVER MODULE
K915879 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 28d
Cleared Jan 24, 1992
INNERVISION LAPAROSCOPE AND ACCESSORIES
K912882 · HET
M.D. Engineering, Inc.
Obstetrics & Gynecology · 207d
Cleared Jan 24, 1992
M. KUROSAKA(TM) FIXATION SCREW
K913210 · HWC
Depuy, Inc.
Orthopedic · 189d
Cleared Jan 24, 1992
SONY DVR-10 DIGITAL VIDEOCASSETTE RECORDER
K913886 · JAA
Sony Medical Electronics Co.
Radiology · 148d
Cleared Jan 24, 1992
MODEL IRC PASSPORT NEBULIZER
K914251 · LAW
Invacare Corp.
Toxicology · 123d
Cleared Jan 24, 1992
VIDEO FLUOROSCOPE
K914414 · JAA
Raymax Medical Corp.
Radiology · 115d
Cleared Jan 24, 1992
THUMPER
K914854 · FRN
Block Medical, Inc.
General Hospital · 88d
Cleared Jan 24, 1992
MULTIPLE DOSE CONTROLLER
K914855 · FRN
Block Medical, Inc.
General Hospital · 88d
Cleared Jan 24, 1992
QUICVAGE
K914907 · KDH
Autovage
Gastroenterology & Urology · 84d
Cleared Jan 24, 1992
ELECTROCARDIOGRAPH TRANSMITTER
K915472 · DXH
Tz, Inc.
Cardiovascular · 49d
Cleared Jan 24, 1992
EARBEAR OTOSCOPE
K915537 · ERA
Earbear Co.
Ear, Nose, Throat · 45d
Cleared Jan 24, 1992
QCA PLUS
K915542 · LLZ
Sanders Data Systems, LLC
Radiology · 45d
Cleared Jan 24, 1992
BTE HEARING AID MULTIFOCUS
K915614 · ESD
Opticon Corp.
Ear, Nose, Throat · 39d
Cleared Jan 24, 1992
TANGENT V
K915853 · IXR
Fischer Imaging Corp.
Radiology · 28d
Cleared Jan 24, 1992
CLINITRON C-II
K920112 · INX
Support Systems Intl.
Physical Medicine · 14d
Cleared Jan 24, 1992
PHILIPS 41 SERIES RAINBOW
K920134 · ESD
Philips Int'L B.V.
Ear, Nose, Throat · 11d
Cleared Jan 23, 1992
FUJINON EVL-F
K912859 · GCJ
Fujinon, Inc.
General & Plastic Surgery · 210d
Cleared Jan 23, 1992
DANTEC UD 5500 MK2
K913169 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 190d
Cleared Jan 23, 1992
CANDELA RETINAL CAMERA
K913314 · HKI
Candela Laser Corp.
Ophthalmic · 182d
Cleared Jan 23, 1992
CARDIO PERFECT, CARDIO PERFECT MD
K913374 · DPS
Cardio Control BV
Cardiovascular · 178d
Cleared Jan 23, 1992
CT SYTEC 8000
K913485 · JAK
General Electric Co.
Radiology · 170d
Cleared Jan 23, 1992
VECTRA MAGNETIC RESONANCE SYSTEM
K913673 · LNH
General Electric Co.
Radiology · 157d
Cleared Jan 23, 1992
SYREX SYRINGE
K913769 · EJI
Special Machinery Co.
Dental · 154d
Cleared Jan 23, 1992
ECONOAID
K914557 · LKY
Gromedco
Gastroenterology & Urology · 100d